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Psychiatric advance directives for people living withschizophrenia, bipolar I disorders, or schizoaffectivedisorders: Study protocol for a randomized controlledtrial – DAiP studyAurelie Tinland, Léa Leclerc, Sandrine Loubiere, Frédéric Mougeot, TimGreacen, Magali Pontier, Nicolas Franck, Christophe Lançon, MohamedBoucekine, Pascal AuquierTo cite this version:Aurelie Tinland, Léa Leclerc, Sandrine Loubiere, Frédéric Mougeot, Tim Greacen, et al. Psychiatricadvance directives for people living with schizophrenia, bipolar I disorders, or schizoaffective disorders:Study protocol for a randomized controlled trial – DAiP study. BMC Psychiatry, BioMed Central,2019, 19 (1), 10.1186/s12888-019-2416-9 . hal-02473095 HAL Id: al-02473095Submitted on 4 Mar 2020HAL is a multi-disciplinary open accessarchive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come fromteaching and research institutions in France orabroad, or from public or private research centers.L’archive ouverte pluridisciplinaire HAL, estdestinée au dépôt et à la diffusion de documentsscientifiques de niveau recherche, publiés ou non,émanant des établissements d’enseignement et derecherche français ou étrangers, des laboratoirespublics ou privés.

Tinland et al. BMC Psychiatry(2019) DY PROTOCOLOpen AccessPsychiatric advance directives for peopleliving with schizophrenia, bipolar Idisorders, or schizoaffective disorders:Study protocol for a randomized controlledtrial – DAiP studyAurélie Tinland1,2* , Léa Leclerc1,2, Sandrine Loubière1,3, Frederic Mougeot4, Tim Greacen5, Magali Pontier2,Nicolas Franck6, Christophe Lançon1,2, Mohamed Boucekine1,3 and Pascal Auquier1,3AbstractBackground: Compulsory admission to psychiatric hospital is rising despite serious ethical concerns. Amongmeasures to reduce compulsory admissions, Psychiatric Advance Directives (PAD) are the most promising, withintensive PAD (i.e. facilitated and shared) being the most effective. The aim of the study is to experiment PsychiatricAdvance Directives in France.Methods: A multicentre randomized controlled trial and qualitative approach conducted from January 2019 toJanuary 2021 with intent-to-treat analysis.Setting: Seven hospitals in three French cities: Lyon, Marseille, and Paris. Research assistants meet each participantat baseline, 6 months and 12 months after inclusion for face-to-face interviews.Participants: 400 persons with a DSM-5 diagnosis of bipolar I disorder (BP1), schizophrenia (SCZ), or schizoaffectivedisorders (SCZaff), compulsorily admitted to hospital within the last 12 months, with capacity to consent (MacCATCR), over 18 years old, and able to understand French.Interventions: The experimental group (PAD) (expected n 200) is invited to fill in a document describing theircrisis plan and their wishes in case of loss of mental capacity. Participants meet a facilitator, who is a peer supportworker specially trained to help them. They are invited to nominate a healthcare agent, and to share the documentwith them, as well as with their psychiatrist. The Usual Care (UC) group (expected n 200) receives routine care.Main outcomes and measures: The primary outcome is the rate of compulsory admissions to hospital during the12-month follow-up. Secondary outcomes include quality of life (S-QoL18), satisfaction (CSQ8), therapeutic alliance(4-PAS), mental health symptoms (MCSI), awareness of disorders (SUMD), severity of disease (ICG), empowerment(ES), recovery (RAS), and overall costs.(Continued on next page)* Correspondence: aurelie.tinland@gmail.com1School of medicine – La Timone Medical Campus, EA 3279: CEReSS –Health Service Research and Quality of Life Center, Aix-Marseille University,27 Boulevard Jean Moulin, F-13005 Marseille Cedex 5, France2Department of Psychiatry, Sainte-Marguerite University Hospital, F-13009Marseille, FranceFull list of author information is available at the end of the article The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication o/1.0/) applies to the data made available in this article, unless otherwise stated.

Tinland et al. BMC Psychiatry(2019) 19:422Page 2 of 13(Continued from previous page)Discussion: Implication of peer support workers in PAD, potential barriers of supported-decision making,methodological issues of evaluating complex interventions, evidence-based policy making, and the importance ofqualitative evaluation in the context of constraint are discussed.Trial registration: ClinicalTrials.gov identifier: NCT03630822. Registered 14th August 2018.Keywords: Facilitated psychiatric advances directives, Advance decision making, Supported decision making, Peersupport workers, Compulsory admissionBackgroundPersons with mental illness can experience fluctuationsin their state of mental health, with their mental capacitybeing more or less altered [1]. In cases where the personbecomes incapable of making decisions and needs care,the use of compulsory care is legally possible and organized with the objective to prevent self-harm and harmto others [2]. When compulsory treatment is used, theprinciple of benevolence prevails over the principle ofautonomy in the ethical balance of the clinician [3].However, an increasing number of studies show the importance of autonomy and self-determination in the recovery from severe mental disorders [4–8], supported bythe claims of activists and legal texts of human rightsbodies [9]. Furthermore, a growing number of studiesshow the harmful impact of compulsory treatment onthe person [10–17]. These two bodies of evidence complicate the assessment of the weight of each ethical argument and bring many dilemmas [18, 19], but do notsystematically lead to a decrease in this type of measure.Indeed, a recent review founded an increase in involuntary admission in 11 of 18 countries surveyed, includingFrance [20]. The published rates vary with a ratio of 1 to19.5 between comparable Western European countries(i.e. Italy and Austria) [20], and between departmentswithin the same country (e. g. in France with a ratio of 1to 6 [21]. Beyond hospitalization, very wide disparitiesare observed throughout the field of research on coercion, that depend on culture, mental health legislation,social context (socioeconomic characteristics, urbanisation) or service configuration [20, 22].These disparities do not inhibit action, and the metaanalysis of de Jong and coll [23]. identified several robuststudies on interventions to reduce compulsory hospitaladmission for persons with severe mental illness, withfour main relevant evaluated approaches: advance statements, community treatment orders, compliance enhancement, and integrated treatment. Among theseinterventions, advance statements were the most promising, showing a statistically significant and clinicallyrelevant reduction in compulsory admissions for adultsin psychiatric hospital [23].In literature, terms “advance statements”; “crisis planning”, “treatment preferences” and “advance directives”are found, with advance directives being the widestspread [20]. Psychiatric advance directives (PADs) arewritten documents that allow adults with decisionmaking ability to declare their care preferences in advance, in order for them to be applied in the event of animpairment of this ability [24]. Specific forms of PADsare described such as crisis cards, treatment plans, Ulysses Directives, Joint Crisis Plan (JCP), facilitated psychiatric advance directives, care plan, advance care plan,advance decision-making, and the Wellness RecoveryAction Plan (WRAP) [25–31]. All these forms of PADhave treatment preferences in common but differ inlegal framework, the presence or not of a facilitator, thesharing conditions, and their content, in particular theirintegration in a self-management plan, and the designation of a health care agent to act on behalf of the personshould he or she be deemed mentally incapable in thefuture [32–36]. PADs are considered to be a complexintervention, with a) several interacting components including the document itself, support by the facilitator,professional and family context, and b) several relevantlevels of implementation including completion of thedocument, content of the document, access to directivesby stakeholders and compliance with directives [37].Considering current literature on the effects of PADsin reducing compulsory admissions as primary outcome,five RCTs of high methodological quality were conducted [38–42]. A recent meta-analysis including thesefive articles showed a 25% reduction in compulsory admissions for people with PADs compared to usual care(risk ratio 0.75, 95% CI 0.61–0.93, P 0.008) [33], with agreater effectiveness of intensive PADs (i.e. facilitated byan healthcare agent and shared with caregivers) amongthe different models used.Beyond their effectiveness on constraint, PADs haveshown an improvement of empowerment and selfdetermination, awareness, comprehension and appropriation of symptoms and partnership [25, 26, 28, 43–48].All studies highlight the importance of one-to-one facilitation to improve drafting, understanding, and sharing of PADs [25, 28, 33].In France, advance directives were created by the lawof April 22, 2005 and mainly used in end-of-life healthcare [49]. PADs are only marginally used by a few

Tinland et al. BMC Psychiatry(2019) 19:422pioneering teams. Specifically in Marseille, a groupdefending the rights of persons living with mental healthproblems has adopted an advance directive documentused in a preliminary study and based on the JCP model.From there, the group has developed a peer supportpractice around the facilitation of PADs in order tomake them more intensive. Introduced in the 1990s inNorth American mental healthcare services, peer support practitioners have experienced mental health challenges and are trained to support others [50]. They playa central role in promotion of recovery and recoveryoriented practices [51]. These PADs have been testedand improved in Marseille by users, peer-workers andclinicians, leading to a final version used in this studyprotocol.To our knowledge, no RCT on PADs has ever beencarried out in France.In order to rigorously evaluate this intervention, amulticentre, randomized controlled study was designed.MethodsAimThe primary objective is to assess the impact of Psychiatric Advances Directives (PAD) in comparison withroutine care by a psychiatrist (Usual Care - UC) on therate of compulsory admissions to psychiatric hospitalover a 12-month follow-up period.The secondary objectives are: (1) to assess the impactof PAD on care-related outcomes (number of inpatientdays, therapeutic alliance), patient reported outcomes(quality of life, satisfaction), mental-health outcomes (recovery, empowerment, awareness of disorders, symptomatology, severity); (2) to measure the costeffectiveness and cost-utility of PAD in comparison withUC; and (3) to describe changes in professional cultureand practices in the different stakeholders, includingusers, usual professionals and facilitators.Design and settingA multicentre, open-label, randomized, controlled, parallel trial is used to evaluate the effectiveness of PADs. Inparallel, a qualitative study is conducted to documentthe recovery trajectories of individuals in the program,institutional dynamics, and professional practices (including facilitator practice) around PADs.Subjects are referred by their psychiatrists, recruitmentis performed in seven hospitals from three main citiesacross France: three Public Institution of Mental Healthin Marseille (AP-HM, Edouard Toulouse, Valvert), twoin Lyon (Le Vinatier, Saint Jean de Dieu ARHM) andtwo in Paris (GHU and Argenteuil). Trained research assistants check eligibility criteria, describe the trial, answer any questions the candidates may have and obtaintheir written informed consent. Participants are thenPage 3 of 13randomly assigned to either Psychiatric Advance Directives (Experimental group) or Usual Care (Controlgroup) – see Fig. 1. The 1:1 randomization is stratifiedper centre and a computer-generated randomization listis created using a permuted block-design. The statistician generated the allocation sequence, psychiatrists andresearch assistants enrol participants, and research assistants assign participants to the intervention groups according to the randomization list.The organization of the study and its various committees are represented in Fig. 2.Inclusion and exclusion criteriaInclusion criteria are as follows: being over 18 years old;having a diagnosis of schizophrenia or bipolar I disorderor schizoaffective disorders according to Diagnostic andStatistical Manual of Mental Disorders, fifth edition(DSM-5) criteria; having been involuntarily admitted tohospital within the past 12 months; having decisionmaking capacity, assessed by a psychiatrist according tothe four key components of a capacity evaluation: understanding, appreciation, reasoning, and choice, from theMacArthur Competence Assessment Tool for ClinicalResearch (MacCAT-CR) [52]; being covered by Frenchgovernment health insurance; and speaking French. Exclusion criteria include the following: being consideredunable to provide informed consent and being underguardianship.Intervention groups- Experimental Group: Psychiatric Advance Directives(PAD). Each person assigned to the experimental groupis invited to fill in a document describing his or her crisis plan and his or her will or preferences in case of being unable to consent,1 and to meet a facilitator speciallytrained to help them with this. He or she is invited toshare the document with his or her psychiatrist and thereliable person he or she has nominated (a healthcareagent). Meetings concerning the document between thepeer support worker and the participant take place assoon as the latter decides to do so, and the support offered lasts as long as necessary. Peer support workersare recruited specifically for this study, and trained together for this protocol, on the one hand to ensure bothcompliance with the protocol and consistency of1The document figures in Additional file 1 (in French). It contains thename and contact of the healthcare agent –the participant’s “reliableperson”, the name of the people to be contacted or not in case of acrisis, the triggering signs and what helps or does not help at thisstage, what helps in case of a crisis and what does not, the procedureto be followed in the event of danger, the treatments and others thingsaccepted during a crisis and those to be avoided, and the choice ofpatient care facilities. Objections, values, and principles can also bestipulated in the document.

Tinland et al. BMC Psychiatry(2019) 19:422Page 4 of 13Fig. 1 Flow Chart of DAiP Study Designpractice, and on the other hand to better define facilitator practice (what time is needed, what are the obstaclesand enablers). Regular exchanges are organised betweenthem, and with the entire research team, via web conferences, and regular meetings during the study.- Control Group: Usual Care (UC). People assigned tothe control group are followed as usual by theirpsychiatrist.No concomitant care or interventions are prohibitedduring the trial participation.Participant time lineFace-to-face interviews to collect quantitative data areplanned with research assistants: inclusion and baselineinterview (M0), 6-month interview (M6) and 12-monthinterview (M12) (see Fig. 3).In the experimental group, research assistants inviteparticipants to meet the facilitator as soon as possible,by proposing an immediate phone call to arrange an appointment. All contact information is provided.Outcome measuresPrimary outcomeThe primary outcome is the rate of involuntary admissions to psychiatric hospital at 12 months of follow-up,from local medical databases, crosschecked and completed with declarative data, in particular for admissionsin other hospitals (non-local).Secondary outcomes– Care-related outcomes: Number of inpatient days measured both fromlocal administrative databases and self-reporteddata Perceived coercion, in particular uponcompulsory hospitalization Therapeutic alliance assessed using the 4-Pointordinal Alliance Scale (4-PAS) [53]. This selfrating scale includes two dimensions (empathyexperienced and psychoeducation) and a globalscore. Higher scores indicate higher therapeuticalliance. Somatic and addictive comorbidity assessed atbaseline by the psychiatrist.– Patient-reported outcomes: Quality of life assessed using theSchizophrenia Quality-of-Life scale (S-QoL18 scale), which comprises 18 itemsevaluating eight dimensions: psychologicalwell-being, self esteem, family relationships,relationships with friends, resilience,physical well-being, autonomy, andsentimental life [54]. Dimension and indexscores range from 0, indicating the lowestquality of life, to 100, the highest quality oflife. S-QoL-18 has been validated in bipolardisorders [55].

Tinland et al. BMC Psychiatry(2019) 19:422Page 5 of 13Fig. 2 DAiP Study Organizational Structure Satisfaction of program users evaluated usingthe CSQ-8, which is the most frequently usedquestionnaire in mental health services [56].The range is from 8 to 32, with higher scoresindicating higher satisfaction. Satisfaction ofcaregivers involved (psychiatrists) is alsoassessed using an adaptation of the CSQ-8.– Mental-health outcomes: Recovery assessed using the RecoveryAssessment Scale (RAS), which measuresvarious aspects of recovery from theconsumer’s point of view, with a particularemphasis on hope and self-determination[57, 58]. This self-administered instrumentcomprises 24 items, exploring five domains:personal confidence and hope, willingness toask for help, goal and success orientation,reliance on others, and not being dominatedby symptoms. A higher score indicates betterrecovery. Mental health symptomatology assessed usingthe self-report Modified Colorado SymptomIndex (MCSI) [59]. This 14-item tool evaluateshow often in the past month an individual hasexperienced a variety of mental healthsymptoms, including loneliness, depression,anxiety, and paranoia. Higher scores indicate agreater likelihood of mental health problems. Empowerment assessed using theEmpowerment Scale (ES) [60] which is aspecific tool for mental health. It comprises fivedimensions: self-esteem, optimism, power,activism, and legitimate anger. Higher scorescorrespond to higher empowerment. Awareness of disorders assessed by thepsychiatrist at M0 and M12, using anabbreviated version of the Scale to AssessUnawareness of Mental Disorder (SUMD), withnine items describing three dimensions:awareness of the disease, consequences and

Tinland et al. BMC Psychiatry(2019) 19:422Page 6 of 13Fig. 3 Schedule of enrolment, interventions and assessment. SPIRIT diagram of DAiP Studyneed for treatment, awareness of positivesymptoms, awareness of negative symptoms[61, 62]. Overall severity assessed using Clinical GlobalImpression (CGI) [63], where the psychiatristrates on a scale from 1 (healthy, not ill) to 7(severely ill) at M0 and M12.– Social outcomes: Gender, age, education level, nationality, socialbenefits, wages, employment status, andhousing conditions assessed using ad hocquestionnaires. Deprivation assessed at baseline using theEPICES score (Evaluation of Deprivation andInequalities in Health Examination Centres).This composite index is commonly used tomeasure the social and material dimensions ofdeprivation [64]. The 11-item version has beenvalidated on a large cohort [65]. EPICES score isrelated to all causes of death, most of the specificcauses of death and to premature and avoidabledeaths. The higher the score, the more deprivedthe person is. Authors defined a cutoff value of30.7 for the threshold defining deprivation.

Tinland et al. BMC Psychiatry(2019) 19:422– Costs: Direct and indirect costs are measured duringthe 12-month follow-up period. Direct costscover the costs related to medical/healthservices, including days in hospital, emergencydepartment visits, and outpatient visits, andindirect costs mainly related to loss ofproductivity. Several sources of data will beused: local medical databases (Department ofmedical information from each centre); medicalrecords; structured interviews with participants,as well as the standardized Short Form-Healthand Labor questionnaire (SF-H&L) [66]. TheSF-H&L measures productivity losses caused byhealth problems in general: absenteeism frompaid work, production losses withoutabsenteeism from paid work and hindrance inthe performance of paid and unpaid work. Cost-utility analysis, measured in qualityadjusted life years (QALYs), using the EQ5Dscale that applies utility values to each state ofhealth [67].Process measurementsEvaluation of the allocation in PAD group (i.e. whetheror not participants have completed the PAD document,shared them and with whom, met with the facilitator,and the time spent with the facilitator) is also recordedin both groups at 6 and 12 months. In addition, the sociologist will compare the dynamics between the centresfor the different levels of implementation identified byNicaise: completion, content, access and honoring [37].Sample sizeSample size was calculated to detect a reduction of 30%in the rate of compulsory admissions to psychiatric hospital during the follow-up period of 12 months betweenthe two groups (consistent with similar RCTs: 29, 39,40), with a reference point of 42.6% [68]. To obtain asignificance level of 2.5% and power of 80% with equalallocation to two arms, each arm of the trial would require 182 people. To allow for a potential 10% of peoplebeing lost to follow-up, 200 will be recruited per arm,i.e. 400 in total. Considering the inclusion potential ofeach participating centre, inclusion is planned to last fora 12-month period. The expected period of participationfor each included individual is 12 months.To promote participant retention, research assistantswere recruited for their interpersonal skills. In addition,participants will receive 20 for each interview. Forpeople lost to follow-up, the primary outcome will becollected from local medical databases.Page 7 of 13Statistical analysisThe data will be summarized using the mean, median,standard deviation and range for quantitative data, andfrequencies for categorical data. Analysis of the primaryand secondary criteria will be performed on the intentto-treat population. In addition, complementary perprotocol analyses will be performed.Comparisons between the two groups for each outcome will be performed using Student’s t-tests or MannWhitney-Wilcoxon tests for quantitative variables, andchi-squared or Fisher’s exact tests for proportions. Nonparametric tests will be used for data that is not normally distributed. Multivariate analyses will be performed primarily using negative binomial or Poissonregression models (for overdispersed data) for the number of involuntary admissions and a gamma distributionfor the number of inpatient days, adjusting for thelengths of follow-up. Explanatory variables will be selected among those for which the P-value is below orequal to 0.20 in univariate analysis. The results will bepresented in the form of standardized beta coefficients.We will use a GEE approach with an exchangeablecorrelation matrix, which assumes that patient outcomesfrom the same centre are correlated but are independentfrom patient outcomes in different centres.Statistical significance is defined as P 0.05. Statisticalanalyses will be performed using SPSS Statistics forWindows, Version 20.0 (SPSS Inc. Chicago, IL, USA) orSTATA 16 (StataCorp. 2019. Stata Statistical Software:Release 16. College Station, TX: StataCorp) LLC.Cost utility analysisHealth benefits and healthcare costs related to interventions targeted to prevent persons with severe mental illness from involuntary hospital admissions should beanalysed in order to inform decision makers, psychiatrists, judges, and relatives of their efficiency [67]. Balancing patient safety with health-related quality of life,hospital length-of-stay (LOS) and associated costs is vital[69]. The aim of the economic analysis is therefore to investigate whether intensive Psychiatric Advance Directives with the peer support would result in significantimproved health-related quality of life and healthcaresavings compared to usual care.To quantify the efficiency of PAD from society’s pointof view, we propose to calculate the incremental costutility ratio (ICUR) of the intervention compared toUsual Care. Incremental benefits will be measured inquality-adjusted life years (QALYs), which is particularlyrelevant here since an expected reduction in involuntaryadmission rate associated with enhanced autonomy andself-determination would have rapid positive impacts onthe patient’s QoL. The time horizon will be 12 monthsafter randomization.

Tinland et al. BMC Psychiatry(2019) 19:422QALYs is calculated by multiplying the number ofyears of life gained by a health-state associated utilityvalue (corresponding to patient’s quality of life) duringthe period under consideration. Preference-based utilityscores will be calculated using the three-level version ofthe EuroQol five-dimensional questionnaire (EQ-5D-3L). This is a validated questionnaire that assesses a participant’s health status in terms of 5 dimensions (mobility, self-care, routine occupations, pain and discomfort,and anxiety and depression) [70].All healthcare resources will be observed, quantifiedand value added throughout the period between baselineand the end of the RCT follow-up. These healthcarecosts will include resources for PAD intervention (including professional time and training), in-patient resources (including compulsory and non-compulsoryhospital admissions), outpatient and home care, andpharmacy claims over the 12-month follow-up period.Cost resources will be valued using data from the FrenchNational Health system and hospital databases, databasesfor medical and paramedical acts, French National official list prices for drugs and registers of pharmaceuticalspecialities. Indirect costs will be estimated using the SFH&L questionnaire but not value added as recommended by the French Health Authority [71].Sensitivity analysis will be carried out to test the robustness of the results. One-way sensitivity analysis and tornado diagrams will be used to identify thresholds forfactors influencing the ICUR. Probabilistic sensitivity analysis, using the non-parametric bootstrap method, will becarried out to generate mean expected ICURs and to determine whether uncertainty or variation in the data affectICURs [72]. In addition, cost-effectiveness acceptabilitycurves will be drawn to represent decision uncertaintysurrounding cost-effectiveness estimates [73].Qualitative analysisThe qualitative evaluation of the PAD program is carriedout by a sociologist for three groups of stakeholders:care users, health professionals and institutions. It aimsto understand, from a recovery perspective, the effects ofthe program on these different actors. Focus groups andsemi-structured interviews with intervention group participants will be done at each site to identify theorganizational and institutional dynamics that are specific to each centre. There will also be individual interviews with psychiatrists, care coordinators, peer supportworkers and participants. At least 28 care users (4 percentre) will be interviewed twice using the life storymethod to describe how the PAD program fits into theirtrajectory. This evaluation process is combined with aparticipatory approach. The various stakeholders are invited to participate in the reflection on the implementation of the program and its generalization. InductivePage 8 of 13thematic analysis, including constant comparisonmethods [73], will be used to analyse data specifically related to explaining the trial outcomes.Data managementThe data entry is done through an e-CRF (electronicCase Report Form) developed using the open sourceweb application REDCap. The access to this applicationis secure and is done with a user id and a password.Each user, and its role in the study, is clearly defined.Data captured through the software is backed up dailyon a secure network. The database of the study is storedon a specific directory of the server, administered by theDigital Services Direction of the sponsor. Data quality isdetailed in data-management and data-validation plans,approved by the principal investigator of the study. Datamanagers structure the data of the included-patients,and check their coherence and reliability. The datamanager provides the database to the biostatisticianonce it is cleaned and frozen.The data management and monitoring team will oversee the intra-study data sharing process. Principal Investigator will be given access to the cleaned data sets. Toensure confidentiality, data dispersed to project teammembers will be blinded of any identifying participantinformation.MonitoringIn the event of interim analysis or definitive discontinuation of the study, the National coordinating team willobtain competent authorities the authorisation. As thisresearch is part of the research involving the human “atrisk and minimal constraints” (categorie 2 in Jardé Law),and in accordance with the regulations in force, it willbe up to the investigator to declare any serious adverseevent that

Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005 Marseille Cedex 5, France 2Department of Psychiatry, Sainte-Marguerite University Hospital, F-13009 Marseille, France Full list of author information is available at the end of the article Tinland et al. BMC Psychiatry (2019) 19:422

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